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NCT Number: NCT06787781

Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects

The therapeutic use of ALA in schizophrenia has recently been investigated in human populations. A case series explored the effiacy of ALA as a novel agent to treat antipsychotic-induced obesity, at a dose of 1200 mg/d (range between 600 and 1800 mg/d); reporting the key effect to be a reduction in body weight and BMI after a 12-week treatment. In a pilot open-label trial, 100 mg/d of ALA was administrated as a general adjuvant to antipsychotics therapy, with no significant improvement in BMI, abdominal circumference, blood count, or liver enzymes. Finally, another study investigated the effects of 500 mg/d of ALA on plasma adiponectin levels, fasting glucose, and aspartate aminotransferase activity, with no significant effect on the metabolic parameters. Based on this background, ALA may be a potentially interesting therapeutic agent to improve the metabolic effects of atypical antipsychotics. The purpose of this study was to assess: (1) the efficacy of ALA on metabolic factors and (2) its safety and potential therapeutic effects in a sample of schizophrenic patients in stable therapy with atypical antipsychotics.

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Key information

Conditions

Metabolic Evaluation Cardiac Complications Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Messina

Messina, 98122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DSM-5 criteria for schizophrenia,
  • aged between 18 and 60 years old
  • in stable atypical antipsychotic monotherapy (clozapine, olanzapine, quetiapine, or risperidone) for least 3 months.

Exclusion criteria

  • treatment with more than one atypical antipsychotic, current treatment with insulin/oral hypoglycaemic/lipid-lowering agents
  • significant concomitant medical pathologies
  • organic brain disorders
  • history of alcohol or substance dependence (excluding nicotine)
  • dementia
  • mental retardation
  • pregnancy/breastfeeding.

Treatment and study plan

Alpha lipoic acid

Drug

ALA was administrated in capsules at a xed oral daily dose of 600 mg for the entire duration of the study in addition to the atypical antipsychotic therapy.

Primary outcomes

  1. Assessing the Effect of ALA on the Blood Parameters: Lipid and Carbohydrate Framework

    Time frame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

    Assessment of metabolic parameters: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), trigycerides, glucose

Secondary outcomes

  1. Total Score Changes Measured by Positive and Negative Schizophrenic Symptoms Scale (PANSS)

    Time frame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

    The PANSS (Positive and Negative Syndrome Scale) is a widely used tool for measuring the severity of schizophrenia symptoms. It assesses positive symptoms, negative symptoms, and general psychopathology in individuals with schizophrenia or related disorders.

    Cut off score of the scale: Total score (range 30-210); severity range: severity ranges:

    Mild symptoms: ~58-75 Moderate symptoms: ~75-95 Marked symptoms: ~95-116 Severe symptoms: ~116+

Other outcomes

  1. Assessing the Effect of ALA on the Blood Parameters: Hepatic Framework

    Time frame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

    alanineaminotransferase (ALT), aspartate aminotransferase (AST), gammaglutamyl transferase (γGT), creatine phosphokinase (CPK)

  2. Assessing the Effect of ALA on the Blood Parameters: Renal Framework

    Time frame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

    Creatinine, Azotemia

  3. Assessing the Effect of ALA on the Blood Parameters: Electrocardiography

    Time frame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

    QTc interval

  4. Assessing the Effect of ALA on BODY MASS INDEX

    Time frame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

    body mass index

  5. Assessing the Effect of ALA on Blood Pressure

    Time frame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

    systolic and diastolic blood pressure

  6. Assessing the Effect of ALA on Prolactinemia

    Time frame: Assessed from enrollment to the end of treatment at 12 weeks, week 12 reported

    prolactinemia

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

Metabolic and Clinical Effect of Alpha-lipoic Acid Administration in Schizophrenic Subjects Stabilized With Atypical Antipsychotics: A 12-week, Open-label, Uncontrolled Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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